Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence
1 other identifier
observational
16,000
1 country
1
Brief Summary
The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine . According to inclusion and exclusion criteria ,the investigators are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia. All enrolled participants must sign a written informed consent.In the preset studio,The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.Then,Statistical experts use quantitative software to quantify the data.The investigators will put all the data and images into a confidential database in order to build a large database of difficult airways. Anesthesiologist will give every patient an endotracheal intubation as planned. After that the anesthesiologist will be asked to fill out the questionnaire immediately.This questionnaire allows obtaining a ground truth for the intubation difficulty.All data will be used for AI deep learning and intelligent analysis,Several of the most relevant landmarks will be selected to build an early warning model.The overall study did not involve any intervention in the process of anaesthesia and operation of the patients, only the three-dimensional facial images of the patients were obtained, without any trauma or injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedAugust 1, 2023
June 1, 2023
3.8 years
June 18, 2020
July 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnosed as a difficult airway
C-L≥Ⅲ grade
Just after intubation
Secondary Outcomes (1)
Difficult mask ventilation
2 minutes after administration of Rocuronium
Study Arms (2)
difficult airway
C-L≥Ⅲ grade
none difficult airway
C-L\<Ⅲgrade
Interventions
The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.
Eligibility Criteria
The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine . According to inclusion and exclusion criteria ,We are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia.
You may qualify if:
- Patients to be intubated under general anesthesia.
You may not qualify if:
- Patients with deaf-mutism or communication disorders.
- Patients with language deficiency or non-native language.
- Patients with mental or central nervous system disease.
- Patients with stupefaction or disturbance of consciousness.
- Patients with terrible injury.
- Patients cannot follow instructions to perform standard actions.
- Patients participated in other relevant clinical investigation in the past 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Study Officials
- STUDY CHAIR
Hong Jiang, Dr
The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
July 7, 2020
Study Start
July 30, 2020
Primary Completion
May 30, 2024
Study Completion
May 30, 2025
Last Updated
August 1, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share